MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY THE SYS 5000-FULL, ENG FP, INT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	60-8018-SYS
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales representative reported on behalf of the customer that 60-8018-sys, the sys 5000-full, eng fp, int was being used on 24nov23 and ¿cautery device would not start cauterizing for a leg vein harvest.The buttons repeatedly would not function.After a time trying to use the pencil, suddenly it started delivering energy intensely and caused a.5cm x1cm burn to the patient's shin near the operative site.Surgeon aware.¿.A good faith effort was made to obtain further information from the reporter; however the reporter has not responded to our attempts for information.This report is being raised on reported injury due to a burn of unknown degree to the patient.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.A device history record (dhr) review was not conducted as the device has been in the field greater than 12 months.The service history was reviewed, and no data was found.A two-year review of complaint history revealed there has been a total of 17 reports, regarding 17 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: dispersive electrodes and probes of monitoring, stimulating and imaging devices can provide paths for high frequency currents even if they are battery powered, insulated or isolated at 50/60 hz.The risk of burns can be reduced but not eliminated by placing the probes as far away as possible from the electrosurgical site and the dispersive electrode.Protective impedances incorporated in the monitoring leads may further reduce the risk of these burns.Needles should not be used as monitoring electrodes during electrosurgical procedures.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that 60-8018-sys, the sys 5000-full, eng fp, int was being used on (b)(6) 2023 and ¿cautery device would not start cauterizing for a leg vein harvest.The buttons repeatedly would not function.After a time trying to use the pencil, suddenly it started delivering energy intensely and caused a.5cm x1cm burn to the patient's shin near the operative site.Surgeon aware.¿ a good faith effort was made to obtain further information from the reporter; however the reporter has not responded to our attempts for information.This report is being raised on reported injury due to a burn of unknown degree to the patient.

• Brand Name: THE SYS 5000-FULL, ENG FP, INT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18544162
• Report Number: 3007305485-2024-00014
• Device Sequence Number: 12990468
• Product Code: GEI
• UDI-Device Identifier: 20653405040979
• UDI-Public: 20653405040979
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K020186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 60-8018-SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic